ARTICLE | Regulation
A role for RWE in the accelerated approval pathway
Real-world evidence is poised to make its mark on confirmatory trials
September 1, 2021 1:04 PM UTC
Real-world evidence is still in its infancy, but as its potential becomes increasingly recognized, doors are opening that could render it a difference-maker in the accelerated approval pathway.
In particular, RWE could be key for opening up accelerated approval to more diseases and making confirmatory trials more informative. ...